Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)
National Heart, Lung and Blood Institute (NHLBI)
Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
Center for Tobacco Products (CTP) (FDA)

Funding Opportunity Title

Tobacco Centers of Regulatory Science for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (P50)

Activity Code

P50 Specialized Center

Announcement Type

New

Related Notices

  • October 5, 2012 - See Notice NOT-DA-13-002. Notice of Availability of Nicotine Research Cigarettes through NIDA's Drug Supply Program.
  • September 21, 2012 - This Notice is to inform applicants that NIAID has joined RFA-DA-13-003. See Notice NOT-AI-12-157.
  • August 1, 2012 - See Notice NOT-DA-12-018. This notice is to inform potential applicants of a pre-application web-based seminar.
  • July 16, 2012 - See Notice NOT-AA-12-006. Notice of NIAAA Participation.

Funding Opportunity Announcement (FOA) Number

RFA-DA-13-003

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.077  

FOA Purpose

This Funding Opportunity Announcement (FOA) invites applications for Tobacco Centers of Regulatory Science (TCORS) using the P50 mechanism.  The TCORS program objective is to conduct programs of multidisciplinary research that will inform tobacco product regulation and address the research priorities related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP).  The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulations. The awards under this FOA will be administered by NIH using designated funds from the FDA CTP for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. Projects resulting from this FOA are expected to serve the FDA by generating relevant findings and data needed to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

Key Dates
Posted Date

July 10, 2012

Letter of Intent Due Date

October 15, 2012

Application Due Date(s)

November 14, 2012

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

April 2013

Advisory Council Review

August/September 2013

Earliest Start Date(s)

September 2013

Expiration Date

November 15, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

PRE-APPLICATION CONFERENCE CALL

The NIH anticipates holding a pre-application conference call or web-based teleconference to which all interested prospective applicants are invited.  NIH Program and Review staff persons will explain the goals and objectives of the Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act funding opportunity announcement (FOA), discuss the application peer review process, and answer questions.  Information about this pre-application conference call will be available at (http://cancercontrol.cancer.gov/nih-fda/funding.htm).

Purpose

This Funding Opportunity Announcement invites center grant (P50) applications for Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act. The overall TCORS program objective is to conduct programs of multidisciplinary research that will inform the manufacture, distribution, and marketing of tobacco products related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP).  The research findings generated from this FOA are expected to provide additional scientific data to inform the regulation of the tobacco products to protect public health. 

The awards under this FOA will be administered by NIH using designated funds [from the FDA CTP] for tobacco regulatory science mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31.  The NIH and the FDA have formed an interagency partnership to foster research relevant to tobacco regulatory science within the framework of the Tobacco Control Act.  Consistent with the FDA CTP mission, this FOA encourages research applications that address such aspects as: understanding the diversity of tobacco products, reducing addiction to tobacco products, reducing toxicity and carcinogenicity of tobacco products and smoke, understanding the adverse health consequences of tobacco use, understanding communications about tobacco products, understanding tobacco product marketing, and understanding how economics and policies affect tobacco product use (http://cancercontrol.cancer.gov/nih-fda/).

Background

Role of the FDA in the FSPTCA:  With the passage of the FSPTCA in June 2009, the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health.  Under Section 901 of the FSPTCA, the FDA has authority to regulate tobacco products.  A tobacco product is defined as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory or a tobacco product)”.  As of August 2011, FDA’s jurisdiction of tobacco products included all cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.  It is anticipated that FDA will assert jurisdiction over all other tobacco products currently not under its jurisdiction that meet the statutory definition of “tobacco product.” (Regulation Identification Number 0910-AG38, Regulation of E-Cigarettes and Other Tobacco Products).  A full description of the FSPTCA can be found at: http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM237080.pdf   Potential applicants should be aware of the requirements of revised Circular A-110, see: http://grants.nih.gov/archive/grants/policy/a110/a110_guidance_dec1999.htm#faqs

Program Scope and Research Objectives

The overall Tobacco Centers of Regulatory Science (TCORS) program objective is to conduct programs of multidisciplinary research that will aid the development and evaluation of tobacco product regulations.  The TCORS program will lead the establishment of a broad national scientific base of tobacco regulatory research.  Although a vast and sound science base exists with regard to numerous areas related to the FSPTCA, new research will provide additional science for FDA to consider as it implements the FSPTCA.  Centers resulting from this FOA are expected to demonstrate research excellence and leadership in tobacco regulatory science that will contribute to the science base FDA will use to develop meaningful product regulation which will in turn reduce the toll of tobacco-related disease, disability, and death in the United States.  Essential elements of TCORS applications include at least 3 theoretically grounded, strong research projects with an integrative theme, an Administrative Core and other cores as needed and justified, use of funds for developmental/pilot and time-sensitive research, and a program for career development and training.  Research integrated across projects, where findings from one major project inform or complement those in another, is strongly encouraged.  Disciplinary integration within a Center, and within projects (again, where feasible) is also encouraged.  Disciplinary diversity in a Center must support the objectives of the science and not merely reflect the training of the scientist.  Meaningful collaboration is permitted across geographically separate sites within a funded Center, and is strongly encouraged across all funded Centers.  Each Center funded under this announcement is expected to participate with the other Centers within the TCORS program on a regular basis to share information, assess scientific progress in the field, identify new research opportunities, participate in one or more cross-site scientific working groups, and form inter-center collaborations to promote discovery, address research gaps, and resolve areas of scientific disagreement.

A TCORS application must propose a program of multidisciplinary research around a unifying or well-defined goal or targeted area of research that will aid the development and evaluation of tobacco product regulations.  Investigators should represent a broad range of disciplines working together to increase knowledge across the full spectrum of basic and applied research on tobacco and addiction.  

The level of specialization in different dimensions of regulatory tobacco research will vary from center to center, e.g., themes, topics, points on the discovery-development-delivery continuum, populations, levels of analysis and types of research (including animal or human, cross-sectional or longitudinal).  However, Centers should focus thematically on areas in which there are significant gaps in knowledge and critical needs--where focused, collective, interdisciplinary efforts could make the greatest difference in reducing tobacco use and its adverse health consequences through the regulation of the manufacture, distribution, and marketing of tobacco products.  Individual Centers may vary in their breadth or concentration across research foci (e.g., molecular to population-based research).  Some may choose to be tightly organized; others may have a broader span.  Research themes may coalesce around a research gap that is tobacco product- or constituent-specific (e.g., smokeless tobacco products, or menthol), that cuts across products (e.g., biomarkers, toxicity, carcinogenicity, or understanding health consequences of tobacco use), or that represents a cross-cutting priority like vulnerable populations (e.g., adolescents, pregnancy status/reproductive age, or racial/ethnic minorities), communications, marketing, or economics.  Centers are encouraged to study interactions across research foci, such as the variation of cultural and individual variables within a research topic, when possible.  It is expected that the Centers will catalyze problem solving and lead to more rapid advances in knowledge than would be possible by depending on individual investigators working in relative isolation.  It is incumbent upon investigators to articulate the gap areas, justify their choice of thematic focus, and indicate how the Center will inform FDAs research priorities. 

Centers are required to have an Administrative Core to monitor and facilitate attainment of Center objectives, and may propose additional Cores as needed and justified (e.g., data, biospecimens, etc.).  Centers are required to have a developmental and pilot projects program to allow the exploration of novel directions, especially those that might arise from the progression of the major projects or that arise due to new and/or collaborative research opportunities.  Collaborative projects, where feasible and when scientifically justified, may be across major research projects within a Center, across two or more Centers, or with scientists outside the TCORS environment.  Centers are encouraged to develop strategies to foster formal and informal intra-, inter-, and extra-center collaborations and cross-site scientific working groups to identify and address overarching conceptual and methodological issues.  Developmental and pilot projects must address the research priorities of the FDA CTP.  Promising pilot studies are expected to spawn new applications for independent funding.  In addition, TCORS applicants will ideally demonstrate an interest in and capacity for the conduct of ad hoc time-sensitive research projects.  Given the potential for rapid change and new developments in tobacco product manufacturing, distribution, and marketing, the TCORS program must be poised to provide national leadership in responding quickly to propose and implement a strong, coordinated research plan in response to new developments.  As such Centers are expected to capitalize on research capacity, investigator expertise, and the network of collaborations in assessing and responding to the research needs of the FDA CTP.

There is an urgent need for investigators who have the quality and breadth of training necessary to conduct cutting-edge research related to the regulation of the manufacture, distribution, and marketing of tobacco products.  As nationally recognized Tobacco Centers of Regulatory Science, Centers are expected to play leadership roles in training new researchers in the field.  A proposed Center application must include a plan for research training and education for pre-doctoral, post-doctoral, and/or cross-training of junior and established investigators who are new to the field of tobacco regulatory science.  Such training should expose trainees, hereafter referred to as appointees, to the multiple levels of research, whether molecular, behavioral, or social, that address tobacco-related issues.  Because tobacco research scientists are widely dispersed by geography and come from an equally wide range of disciplines, this type of training is difficult to obtain.  A unique opportunity is afforded the TCORS program to create collegial and collaborative networks among the TCORS' appointees and training programs.  Centers are expected to develop mechanisms for establishing these networks and for sharing training resources, including curricula/courses, research opportunities, and mentors/educators.  The Centers are expected to develop a strong training program and should propose a plan to provide for appointees to maximize their opportunities for developing  independent research projects and for professional development.  The research training and education program must be led by a senior investigator with significant experience in mentoring and a strong training record.

Finally, Centers are expected to communicate, coordinate, and when appropriate, collaborate with other Centers in the research network.  Due to the anticipated diversity of the research themes, projects, populations, and data of the Centers to be funded under this announcement, a single common study protocol will not be feasible, and as such Centers are expected to plan, direct, and execute their own data management and statistical analyses.  However, use of common study variables, criteria, and protocols, where appropriate, is expected to facilitate future analyses of the data aggregated across studies.  As such, after awards are made, investigators will be encouraged to collaborate with other awardees on the development and use of shared and standardized measures, methods, and data management wherever feasible to facilitate data aggregation and collaborative activities among Centers.  For example, investigators will likely be expected to adopt common measures for nicotine dependence or the biochemical validation of smoking abstinence.  The variable naming and data coding conventions for TCORS databases may be shared to develop common coding and naming conventions across Centers to facilitate data aggregation.  Such coding and naming procedures may be helpful in data sharing, particularly for any data sharing based on the requirements of Circular A-110 (http://grants.nih.gov/archive/grants/policy/a110/a110_guidance_dec1999.htm).  Communication and collaboration across the TCORS program will also be critical to program assessment of scientific progress in the field, identification of new research opportunities, formation of collaborations to promote discovery and to resolve areas of scientific controversy.

Research Priorities of the FDA Center for Tobacco Products

Science will inform FDA in regulation of the manufacture, marketing, and distribution of tobacco products in order to reduce the public health toll from tobacco product use in the United States.  The research supported by this initiative will provide scientific evidence within the following seven FDA CTP research interest areas:

Vulnerable populations referenced in research questions include, but are not limited to age, gender, race, ethnicity, income, occupation, geographic location, people with mental health or medical co-morbidities, the military/veterans, the lesbian, gay, bi-sexual, transgendered, questioning (LGBTQ) community, and pregnant women/women of reproductive age. Additional information, including a detailed list of 56 FDA CTP research priorities can be found at: http://cancercontrol.cancer.gov/nih-fda/research.htm.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon funding availability, and the submission of a sufficient number of meritorious applications.

NIH , via support from the FDA Center for Tobacco products (CTP), intends to fund up to 12 centers, corresponding to a total of up to $40 million, for fiscal year 2013. Future year amounts will depend on availability of funds.

Award Budget

A P50 center may not exceed $4 million in total costs per year .

Award Project Period

Applicants may request a project period of up to five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

The Program Director(s)/Principal Investigator(s) [PD(s)/PI(s)] will have responsibility for planning and coordination of the Center program, preparation of the budget and oversight of expenditures, staff appointments, space allocation, and other aspects of management and operation of the Center.  The application also may designate an Administrative Core Director who will be responsible to the Center Director and provide direct supervision of the administrative and operational aspects of the Center program.  Such a person should be an individual who has established scientific credentials and who is capable of providing the leadership essential to the success of the Center program.  The PD(s)/PI(s) will be responsible for assuring interaction and collaboration among scientists conducting research within the Center to facilitate a concerted approach to the research goals of the Center.  The PD(s)/PI(s) also will be responsible for the direct monitoring of ongoing research and identifying (with the assistance of colleagues) research and educational activities to be expanded or decreased and needs for additional resources or reallocation of resources.  

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Kay Wanke, PhD MPH
Epidemiology Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5152
Bethesda, MD 20892-9589 (U.S. Postal Service Express or regular mail)
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-402-0036
Email: wankek@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies, and all copies of the Appendix files in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)  

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following al requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Only applications that focus on tobacco regulatory science relevant to the Family Smoking Prevention and Tobacco Control Act will be considered responsive to this FOA.  As this FOA is funded by the NIH via support from the FDA Center for Tobacco products (CTP), all research conducted within the Centers must fall within the regulatory authority of the FDA CTP. Indicating how your Center/research theme/research projects will address FDA CTP research priorities is strongly advised.    

TCORS Program Requirements:  Reviewers will evaluate each Center using the criteria listed below.  Each criterion will be addressed and considered by the reviewers in

assigning the overall score for project merit:

Research Strategy  (12 pages):

Tobacco Centers of Regulatory Science (TCORS) must have a minimum of six (6) components (an administrative core, three research projects, a developmental/pilot project program,  and a training/education program).  At least three research projects and the training program must be active at all times.  All applications for NIH funding must be self-contained within specified page limitations per component.  Pages not used for one component may not be used to extend the page limit of other components or cores. In addition to the overall Center budget, each component requires a separate detailed budget.

Competitive applications will reflect more than an interesting collection of components; there must be evidence of the potential for a meaningful Tobacco Center of Regulatory Science with a real theme and identity.  The Center and its components should result in the generation of new knowledge in tobacco regulatory science. The coordination among the scientific cores, the research projects, the developmental/pilot projects, and the research training and education program should be adequately explained.  Coordination, communication, and collaboration are also expected across the Centers, including the development and use of standardized measures, methods, and data management whenever feasible, the development of collaborative research projects, and the support for collaboration among training appointees and investigators across Centers.

The Center PD(s)/PI(s) should be (an) expert(s) in tobacco research, with, at minimum, R01-equivalent research experience, and ideally with experience successfully leading large multi-disciplinary research projects.  The PD(s)/PI(s) should make substantial time and effort commitments and demonstrate willingness to coordinate/collaborate within the proposed Center (that is, across the Center components) and across the TCORS program (that is, among the Centers funded under this FOA). 

Research Projects (12 pages for each research project): 

A proposed Center must include a minimum of three fully developed R01-level research projects that contribute individually to the goals of the Center program and collectively to the integrative theme.  There must be evidence of multidisciplinary integration within each of the proposed research projects which reflects hypothesis-driven research.  Each research project director should be a qualified investigator and is responsible for the scientific direction and conduct of the individual research project.  Each proposed research project should provide a clear description of its major goals, objectives, and how it integrates with the other research projects and/or Center components.  Each research project should address an important problem or a critical barrier to progress in the field of tobacco regulatory science. A description of how the aims of the research project will improve scientific knowledge, technical capability, and/or tobacco regulatory decision-making is strongly advised.

Administrative and other Cores (6 pages for each core): 

All Centers are required to have an Administrative Core.  The Administrative Core should promote an environment of communication and collaboration among investigators 1) within the proposed Center, 2) across the Centers funded under this announcement, and 3) with the FDA and NIH administrative team.  The Administrative Core must monitor and facilitate attainment of Center objectives, including quality control and oversight mechanisms for ongoing projects.

Where justified, an application may propose shared technical, statistical and/or laboratory resources, creating a core for centralized management (e.g., data, biospecimens, etc.).  The justification for the need of a core service or resource should be clearly stated, along with the scientific and technical merit of the proposed core.  The core director(s) must be appropriately trained, qualified and well suited for the core activities proposed and must commit sufficient time and effort.

Developmental/pilot research component (6 pages): 

The application must provide proposed processes for conceiving, vetting, evaluating, and implementing developmental and pilot research projects that support the exploration of new ideas, methods, and collaborations.  The goal of this component is to allow exploration of novel directions, especially those that might arise from the progression of the major projects or that arise due to new and/or collaborative research opportunities.  Collaborative projects may be across major research projects within a Center, across two or more Centers, or with scientists outside the TCORS environment.  The application ideally will outline strategies to foster formal and informal intra-, inter-, and extra-center collaborations to identify and address overarching conceptual and methodological issues.  The application should propose an institutional review process that selects developmental and pilot projects for within-center funding that are not only methodologically rigorous and scientifically sound but also address the research priorities of the FDA CTP.  The description of this component should focus on the process of solicitation and selection of pilot projects rather than on the research projects or ideas.  However, applicants may supply a short description of up to two eligible projects as examples.  A proposed budget for the implementation of developmental and pilot projects must be included in the application.  In addition, the application should address the interest in and capacity for the conduct of ad hoc time-sensitive research projects.  Given the potential for rapid change and new developments in tobacco product manufacturing, distribution, and marketing, the TCORS program is expected to provide national leadership in responding quickly to propose and implement a strong, coordinated research plan in response to new developments.  While the application may provide a description of an internal process for prioritizing, vetting, evaluating time-sensitive research proposals that are funded within the Center as part of the developmental/pilot research component, it is anticipated that the funding for substantial time-sensitive projects will be made through awarding of competitive and/or administrative supplements.  

Research Training and Education Plan (6 pages): 

A proposed Center must include a plan for research training and education for pre-doctoral, post-doctoral, and/or cross-training of junior and established investigators who are new to the field of tobacco regulatory science.  While not required, the research training and education program in a Center can be elevated to a core.  The research training and education program must propose a program with a minimum of 4 appointees for training whose appointments are made no later than the second year of the grant award.  The training and education program must be led by a Training Director who is an established investigator and who is senior in terms of mentoring appointees at the career levels proposed, publication productivity, and a solid record of obtaining funding and placing those they have trained in excellent positions.  The applicant institution must demonstrate or give reasonable assurances that it has the capacity to train predoctoral and/or postdoctoral students (if proposed) for careers in tobacco regulatory science, and the capacity to conduct programs of continuing education in the Center's designated research theme.  If cross-training of junior and/or more established investigators is proposed, the applicant must describe and justify the intent and expected outcome of this training with regard to tobacco regulatory science.  A plan to facilitate engagement with the training and education programs and appointees across the TCORS programs should also be included for coordination between the proposed Center and the training programs of the other funded Centers in the TCORS program. 

The training plan must indicate the applicant’s openness to work across the TCORS training programs and provide concrete plans to facilitate the development of: communication and collaboration networks; meeting opportunities; and propose shared training programs, curricula, and dissemination activities for the appointees.  Centers are encouraged to develop curricula and training opportunities in their area(s) of expertise, and to make this content available to the appointees from other funded Centers, whether through shared curricula, webinars, or short courses.  At minimum, each Center must develop at least one course in their area of expertise/themes by the end of year 2 and make it available to other funded Centers in the TCORS program no later than the end of year 3.  Professional development must also be provided, to include at minimum training in grantsmanship and in the responsible conduct of research.  During the period of appointment, short or even longer periods of appointee placement at other Centers in the TCORS program for training and collaboration may be proposed and is encouraged for appointee’s professional development.  Center investigators and/or staff may participate in the development and implementation of educational activities for training programs, and Center resources may be made available for use by appointees.  Recruitment of investigators from underrepresented racial and ethnic groups and disadvantaged backgrounds is also encouraged.  The application should provide budgetary support for appointee travel to in-person TCORS investigator meetings and to attend national conferences to present findings and for networking, educational and professional development opportunities.  The application should also provide a plan and evidence for institutional commitment for budgetary support for the development of appointees’ independent research projects, whether through the pilot/developmental research program, the Center research projects, and/or through collaboration with appointees and/or investigators from other funded Centers.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide,

Foreign Institutions

Foreign (non-US) Institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

The application should provide a clear and concise description of the interrelationships among the members of the team, their relevant experience and expertise, and the contribution of each to fulfillment of the objectives of this FOA.  In addition, the applicant should provide a plan to ensure the maintenance of close cooperation and effective communication among members of the applicant’s team and evidence of the capability of the applicant organization to participate and interact effectively in cooperative multi-center research.  Applicants should state their general support of collaborative research and their willingness to participate in a collaborative and interactive manner with other funded Centers and NIH and FDA scientific administrators. 

In order to advance the goal of widespread data sharing among tobacco regulatory science researchers, and to fulfill the requirements of Circular A-110, investigators funded under this announcement are expected to share data.  As such, the application should detail a plan and budget for long-term data sharing and management.

Investigator meetings:

Meetings will be convened up to twice a year throughout the project period to consider, as appropriate, common data elements, cross-site projects, developmental and time-sensitive research projects, and dissemination of research findings. The meetings will also provide the opportunity for the investigators to share scientific information and data, assess scientific progress, identify new research opportunities, and foster interactions between new and established tobacco control researchers.  At minimum, the PD(s)/PI(s), lead investigators of major research projects, and training appointees are required to attend in-person investigator meetings.  Funds to support travel of the key investigators and training appointees to attend these meetings should be included the application budget, with at least one of the annual meetings to be held in the Bethesda/Rockville, Maryland area.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.  

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important issue or a critical barrier in regulatory authority over tobacco products?  If the aims of the project are achieved, how will regulatory science research be informed or regulation affected? How will successful completion of the aims have affect on the concepts, methods, technologies, or regulation of tobacco products?

Investigator(s)    

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Will the project aid in advancement of developing and evaluating regulations pertaining to the manufacture, distribution, and marketing of tobacco products in order to protect public health?  Will the outcomes of the project provide new information addressing regulatory authority over tobacco products?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?  Is the project directly relevant to a specific section in the Family Smoking Prevention and Tobacco Control Act? If the project is in the early stages of development, will the strategy establish feasibility and are risky aspects addressed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?     

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS)

The research findings generated from this FOA are expected to provide scientific underpinnings to inform the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.  As such, it is expected that research data generated from this FOA will be available for additional scientific inquiry in support of tobacco regulatory development and be consistent with Circular A-110, (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_chart.doc).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Additional Review Criteria of Program Components and Management

Reviewers will also consider the review criteria below in the determination of scientific merit, but will not give scores for these items.  However, these criteria should be considered in providing an overall impact/priority score. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a component that by its nature is not innovative may be essential to advance a field.

Center Coordination and Synergy:

Is there evidence of the proposed Center's coordination/integration/collaboration across the Center components (Cores, Research Projects, Developmental/Pilot Projects, Training and Education Program) and across the TCORS program (that is, among the Centers funded under this FOA as well as NIH and FDA scientific administrators and coordinators)?

Developmental/Pilot Projects:

Is the process for developmental/pilot projects well-described, including an explanation of the selection, monitoring, oversight procedures and continuation decisions, and allowing for the potential to develop into (a) full-scale independent project(s)?

Research Training and Education Plan:

Does the proposed Training Director have the required expertise in the subject matter, sufficient seniority in mentoring students at the pre- and postdoctoral levels, and adequate experience in supervising faculty? Can the proposed training program adequately provide the expertise, resources, and institutional commitment to train students and/or crosstrain investigators and move them towards independence for careers in tobacco regulatory science?  Have they provided adequate plans for networking and collaboration and for course and curriculum development for the training appointee career levels proposed?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s)convened by the CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

An Interim Report will be due at the end of five (5) months follow the project start date.  Electronic copies should be sent to the Grants Management Specialist and Program Officer listed on the Notice of Grant Award with a copy to TobRegRes@mail.nih.gov.  The Interim Report will use the Non-Competing Continuation Progress Report; PHS 2590 (Revised 06/2009)

http://grants.nih.gov/grants/funding/2590/2590.htm.  The Interim Report should include: Form Page 1, Form Page 1-Continuation, Project/Performance Site Format Page - use only if additional space is needed; Form Page 5: Progress Report Summary, and Continuation Page as needed.  The scientific summary should be a maximum of two (2) pages.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.      

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Kay Wanke, PhD, MPH
Epidemiology Research Branch
Division of Epidemiology, Services and Prevention Research
National Institute on Drug Abuse (NIDA)
(301) 402-0036 (Direct)
(301) 443-6504 (Main)
(301) 443-2636 (Fax)
Email: kay.wanke@nih.gov

Elizabeth M. Ginexi, PhD
Tobacco Control Research Branch
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
(301) 435-6387 (Direct)
(301) 496-8675 (Fax)
Email: LGinexi@mail.nih.gov

Antonello Punturieri, M.D., Ph.D.
Program Director
Division of Lung Diseases
National Heart, Lung, and Blood Institute
2 Rockledge Centre Suite 10018
6701 Rockledge Drive
Bethesda, MD 20892
(301) 435-0230 (Direct)
(301) 480-3557 (Fax)
Email: punturieria@nhlbi.nih.gov

Srikanth S Nadadur, M.Sc., Ph.D.
Cellular, Organs and Systems Pathobiology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences (NIEHS)
(919) 541-5327 (Direct)
(919) 541-1919 (Main)
(919) 541-0462 (Fax)
Email: nadadurs@niehs.nih.gov

Caroline Signore, MD, MPH
Pregnancy and Perinatology Branch
Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD)
(301) 496-5577 (Direct)
(301) 496-5575 (Main)
(301) 496-3790 (Fax)
Email: signorec@mail.nih.gov

Amy Goldstein, PhD
Child and Adolescent Treatment and Preventive Intervention Research Branch
National Institute of Mental Health (NIMH)
(301) 496-7227 (Direct)
(301) 443-4045 (Fax)
Email: goldsteinam@mail.nih.gov

Randall R. Stewart, Ph.D.
Division of Extramural Research
National Institute of Neurological Disorders and Stroke (NINDS)
(301) 496-6460 (Direct)
(301) 496-1917 (Main)
(301) 402-1501 (Fax)
Email: stewartr@ninds.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: (410) 254-1853
Email:  wellse2@nida.nih.gov

Carol A. Perry
National Cancer Institute (NCI)
Telephone: (301) 496-7205
Email: perryc@mail.nih.gov

Dorothy Duke
National Institute of Environmental Health Sciences (NIEHS)
Telephone: (919) 541-2749
Email: duke3@niehs.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Rebecca Claycamp, MS, CRA
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
Email: rclaycam@mail.nih.gov

Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9231
Email:  decostert@ninds.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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